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Continuous Use of COCs

Continuous Versus Cyclic Use of Combined Oral Contraceptive Pills

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00570440
Enrollment
362
Registered
2007-12-11
Start date
2007-08-31
Completion date
2010-10-31
Last updated
2011-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy Prevention

Keywords

AE adverse event, AIDS acquired immunodeficiency syndrome, ALT (SGPT) alanine aminotransferase, ART antiretroviral therapy, AST (SGOT) aspartate aminotransferase, DCF data collection forms, DMC Data Monitoring Committee, FDA (U.S.) Food and Drug Administration, GCP Good Clinical Practice guidelines, HB sAg Hepatitis B surface antigen, ICH International Conference of Harmonisation, IND Investigational New Drug Application, IRB Institutional Review Board, IU international units, mg milligram(s), mm3 cubic millimeter(s), PCR polymerase chain reaction, SAE serious adverse event, µg microgram, ULN upper limit of the normal range, WB Western Blot

Brief summary

The primary objective is to determine if continuous COC use leads to higher continuation rates over 12 months of follow up than use of the standard 28-day COC regimen.

Detailed description

Family Health International has recently initiated a USAID funded study to investigate the pregnancy rates, continuation rates, and acceptability of COCs in women taking COCs by the 21/7 cyclic regimen compared with the continuous use of COCs with bleeding-signaled hormone-free intervals. The primary objective is to determine whether continuous COC use leads to higher 12-month continuation rates than use of the standard 28-day COC regimen. Secondary objectives are to 1) compare pregnancy probabilities through 6 and 12 months between the continuous use group and the 28-day group 2) compare COC continuation rates through 6 months between the continuous use group and the 28-day group 3) compare acceptability of the two COC regimens 4) to compare bleeding and other side effects between the continuous use group and the 28-day group 5) to compare hemoglobin/hematocrit between the continuous use group and the 28-day group

Interventions

DRUGOral contraceptives--ethinyl estradiol, levonorgestrel

3 visits - screening/enrollment, 6-months and 12 months

Sponsors

La Asociación Pro Bienestar de la Familia de Guatemala (APROFAM)
CollaboratorOTHER
FHI 360
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 30 Years
Healthy volunteers
Yes

Inclusion criteria

* Age 18-30 * Currently has menstrual periods every 21-35 days * Willing and able to be randomly assigned to one of the two study groups and to comply with all study requirements * Has signed the informed consent form * Has a negative urine pregnancy test at enrollment

Exclusion criteria

* Has contraindications to COC use (see WHO MEC-3rd edition) * Is in any other research study * Has been pregnant in the past 3 months * Is breastfeeding or has breastfed in the past 3 months * Is currently using an IUD (women who agree to IUD removal are eligible once the IUD is removed) * Has had an injection of DMPA in the past 6 months * Has had an injection of NET-EN in the past 3 months * Has used combined injectables, oral contraceptive pills, implants, or a hormonal IUD in the past 2 months * Has had any of the following conditions since her last pregnancy, or since menarche if never pregnant: * Pelvic infection treated with antibiotics * Diagnosis of infertility * Endometriosis

Design outcomes

Primary

MeasureTime frame
12 month cumulative COC discontinuation probabilities12 months

Secondary

MeasureTime frame
Pregnancy rates through 6 and 12 months; 6 month cumulative discontinuation probabilities; acceptability; bleeding and other side effects; hemoglobin/hematocrit12 months

Countries

Dominican Republic, Nicaragua

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026